Status:
COMPLETED
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Novartis
Conditions:
Acute Lymphoblastic Leukemia
Philadelphia Chromosome
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.
Detailed Description
Recent advances in treatment have increased the cure of childhood ALL to 75% or better. However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have been largely unsuccess...
Eligibility Criteria
Inclusion
- Children and adolescents aged 1 to 17 years at diagnostic
- Documented Ph+ ALL
- Eligibility for the current local prospective therapeutic study of childhood ALL
- Informed consent given by the parents or by legal guardian
Exclusion
- Abnormal hepatic functions
- Abnormal renal functions
- Active systemic bacterial, fungal or viral infection
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00287105
Start Date
December 1 2005
End Date
March 3 2017
Last Update
May 24 2023
Active Locations (22)
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1
Service d'hématologie pédiatrique CHRU
Amiens, France, 80080
2
Service hématologie pédiatrique Hôpital Saint-Jacques
Besançon, France, 25000
3
Service d'hémato-oncologie - Hôpital des Enfants Pellegrin
Bordeaux, France, 33076
4
Hôpital Morvan
Brest, France, 29200